JP2021151509A - Embolic device and method of manufacturing the same - Google Patents

Abstract

To provide an embolic device formed of a braided member which never moves to the outside of an aneurysm sac when delivered to an aneurysm.SOLUTION: A flat embolic device 10 has a first side comprising a first side surface 14, and a second side comprising a second side surface 16 facing an opposite direction to the first side surface 14. The embolic device 10 has an elongated constrained configuration for being deployed through a delivery catheter, and a three-dimensional unconstrained configuration. In the three-dimensional unconstrained configuration, the embolic device 10 assumes a plurality of successive loops 12 in which the embolic device 10 is at least partially twisted between the plurality of successive loops 12, so that the first side surface 14 faces exterior of each loop 12, and the second side surface 16 faces an interior of each loop 12, respectively, regardless of a change in direction and/or orientation of the embolic device 10.SELECTED DRAWING: Figure 1

Description

The invention disclosed herein relates to an embolic device. More specifically, the present disclosure relates to a method of manufacturing an embolic device.

Medical devices such as coils, tubular mesh elements, and other expandable members, collectively referred to below as "embolic devices," are commonly used to treat various types of angiopathy, especially aneurysms. An aneurysm is a disease in which a blood vessel is locally filled with blood and dilates, local blood flow / pressure is applied to the blood vessel, and / or the blood vessel wall is weakened. Aneurysms usually take the form of a sac or balloon extending from a blood vessel. Aneurysms can rupture and result in bleeding, stroke (eg, cerebral aneurysms), and other injuries to the patient. When treating an aneurysm, the embolic device is loaded into the delivery system in a folded or radially compressed delivery configuration and then introduced into the aneurysm sac. Once delivered within the aneurysm sac, the embolic device dilates or expands into a dilated form to fill and occlude the aneurysm. Embolic devices can come in a variety of sizes and shapes. However, embolic devices for the treatment of aneurysms, when placed within the aneurysm sac, usually take a secondary form of sphere. When implanted in the sac, the embolic device will occlude the aneurysm while further reinforcing the inner wall of the aneurysm sac, reducing the likelihood of rupture or preventing further rupture of the aneurysm.

Embolic instruments are generally composed of self-expanding materials that allow the unrestrained instrument to expand without assistance when the instrument is placed from the delivery system at the patient's target site. There is. The self-expandable embolic device may be urged to inflate when released from the delivery catheter and / or include a shape memory element that allows the device to expand when exposed to a given situation. You can also. Some embolic devices can be characterized as hybrid devices that have the characteristics of both self-expanding and non-self-expanding materials.

Embolic instruments can be made from a variety of materials, including polymers (eg, non-bioerosive and bio-erosive plastics) and metals. Biodegradable polymer embolic devices are desirable in some applications because of their biodegradability and generally greater flexibility compared to metal embolic devices. Embolic instruments can be made from shape memory or superelastic materials such as shape memory metals (eg shape memory nitinol) and polymers (eg polyurethane). Such shape memory embolic devices can be induced (eg, by temperature, electric or magnetic field, or light) to have a shape (eg, a radial extension) after delivery to the treatment site. .. Superelastic embolic materials such as superelastic nitinol take post-delivery shape without the need for evoked stimuli. Other appliance materials include stainless steel, platinum and Elgiloy. In drug delivery embolic devices, the device can hold and / or coat the device with a bioactive agent or therapeutic agent (eg, a thrombus inducer).

A commonly used embolic device is a spiral wire coil with windings sized to engage the wall of the aneurysm. However, the embolic coil can move out of the aneurysm sac, especially when delivered to a wide range of aneurysms.

For example, U.S. Pat. No. 4,499,069 describes some exemplary embolic coils that form a linear spiral configuration when stretched and a convoluted configuration when relaxed. The coil is disclosed. The stretched configuration is used to place the coil at the target site (by passing through the delivery catheter), and when the instrument is placed at the target site, the coil becomes a rotating and relaxed configuration. The 069 patent discloses various secondary shapes of the embolic coil when placed at the target site, such as a "flower" shape, a double vortex, and a random convoluted shape. Other three-dimensional embolic coils include US Pat. No. 5,624,461 (ie, three-dimensional filled embolic coil), No. 5639277 (that is, an embolic coil with a twisted spiral shape), No. 5649949 (that is, a twisted spiral shape). Conical embolic coil with varying cross section). U.S. Pat. Nos. 5,690666 and 5826587 also describe embolic coils with little or no inherent secondary shape.

A spherical embolic device is described in US Pat. No. 5,645,558, where one or more so as to form a nearly hollow spherical or oval shape with overlapping strands when placed within an aneurysm. It is stated that the strands can be wound. Other embolic devices that become spherical when placed are described in US Pat. No. 8,998,947, where they form a nearly spherical shape with overlapping petal-like sections when placed within an aneurysm. A tubular mesh with petal-like sections is disclosed.

Various delivery assemblies for embolic instruments are also known. For example, U.S. Pat. Nos. 5250071 (ie, interlocking clips), 5312415 (ie, interconnected guidewires for delivering multiple coils), Guggiermi Nos. 5354295 and 6425893 (ie). That is, electrolytic separation) and the like.

In an exemplary embodiment of the disclosed invention, the embolic device is formed from an elongated flat member having a longitudinal axis, the first side having a first side surface and the second side having a second. The first side and the second side are opposite to each other so that they have sides and the first and second sides are opposite. The elongated flat member has an elongated constrained configuration for placement at the target vessel site through the delivery catheter and a three-dimensional unconstrained configuration, the elongated flat in the three-dimensional unconstrained configuration. The member becomes a plurality of continuous loops, and the elongated flat member is twisted at least partially around the longitudinal axis between each of the plurality of loops to change the direction and / or orientation of the elongated flat member. Regardless, the first side surface faces the outside of each loop and the second side surface faces the inside of each loop.

The elongated flat member can be, but is not limited to, a braided body formed from one or more braided members, wherein the one or more braided members are metal filaments or wires. For example, the elongated flat member can be a flat tubular braid or a single layer flat ribbon braid.

In an exemplary embodiment, a three-dimensional unconstrained configuration is provided by heat treating an elongated flat member, with elongated flat members alternating around each post extending outward from the mandrel. By winding in the direction of, a plurality of continuous loops are formed. In a preferred embodiment, the plurality of contiguous loops are a first loop defining a first plane, a second loop defining a second plane not coplanar with the first plane, and a first loop. And at least a third loop that defines a third plane that is not coplanar with either of the second planes. In one exemplary embodiment, the plurality of contiguous loops has at least 5 contiguous loops.

In a more specific exemplary embodiment, an embolic device for occluding an aneurysm is provided, the occlusive device comprising an elongated flat braid formed from one or more metal braided filaments or wires in the longitudinal direction. A first having a shaft, a first side having a first side surface, and a second side part having a second side surface, such that the first side surface and the second side surface are opposite to each other. The side and the second side are opposite to each other. The elongated flat braid has an elongated constrained configuration for placement within the aneurysm through the delivery catheter and a three-dimensional unconstrained configuration after exiting the delivery catheter and being placed within the aneurysm. In a three-dimensional, unconstrained configuration, the elongated flat braid becomes multiple continuous loops, and the elongated flat braid is at least partially around the longitudinal axis between each of the multiple loops. Regardless of the twisted, elongated flat braid orientation and / or orientation change, the first side faces the outside of each loop towards the inner wall of the aneurysm, and the second side faces each. It is designed to face the inside of the loop.

As an example, an elongated flat braid can be a flat tubular braid or a single layer flat ribbon braid, a three-dimensional unconstrained configuration by heat treating the elongated flat braid. A plurality of continuous loops are formed by applying to an elongated flat braid and wrapping an elongated flat member in between in alternating directions around each post extending outward from the mandrel. Preferably, the plurality of consecutive loops has at least three consecutive loops, defining a first loop that defines a first plane and a second plane that is not coplanar with the first plane. It includes a second loop and a third loop that defines a third plane that is not coplanar with either the first and second planes. In one embodiment, the plurality of consecutive loops has at least 5 consecutive loops.

The embodiments and features of the other further embodiments will be apparent by the following detailed description with reference to the accompanying drawings.

FIG. 1 is a perspective view of an embolic device manufactured according to the disclosed embodiment of the present invention. 2A-B is a cross-sectional view of the delivery configuration and arrangement of the embolic device of FIG. 1 at the target site according to the disclosed embodiment of the present invention. 3A-B are perspective views and cross-sectional views of an elongated flat member for manufacturing the embolic device of FIG. 1 according to the disclosed embodiment of the present invention. 4A-B are cross-sectional views of the elongated flat member of FIG. 3A according to another embodiment of the disclosed invention. 5A-C is a side view of an elongated flat member according to another embodiment of the present invention disclosed. 6A-C are side views of the end of the embodiment of FIG. 5B according to the disclosed embodiment of the present invention. 7A-B are perspective views of an elongated flat member according to another embodiment of the present invention disclosed. 8A-B are perspective views of an elongated flat member according to yet another embodiment of the disclosed invention. FIG. 9 is a perspective view of the elongated flat member of FIG. 3A in the mandrel for manufacturing the embolic device of FIG. 1 according to the disclosed embodiment of the present invention. FIG. 10 is a perspective view of the elongated flat member of FIG. 3A in another mandrel for manufacturing the embolic device of FIG. 1 according to the disclosed embodiment of the present invention. FIG. 11 is a perspective view of a partial twist of an elongated flat member according to the embodiments of FIGS. 9 and 10. FIG. 12 is a twisted perspective view of an elongated flat member for illustration purposes. FIG. 13 is a schematic view of a method of manufacturing the embolic device of FIG. 1 according to the disclosed embodiment of the present invention.

For the terms defined below, these definitions shall apply unless otherwise defined in the claims or elsewhere herein.

All numbers herein are modified by the term "about", whether explicitly stated or not. The term "about" usually refers to a range of numbers that one of ordinary skill in the art would consider to be equivalent (ie, have the same function or result) to the numbers given. Often, the term "about" includes the number rounded to the nearest significant digit.

The description of the numerical range by end point includes all numbers within that range (eg, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4 and 5). ).

As used herein and in the appended claims, the singular forms "a," "an," and "the" also include multiple referents unless explicitly stated in their content. .. As used herein and in the appended claims, the term "or" is commonly used with the meaning "and / or" unless explicitly stated in its content. ..

Various examples will be described below with reference to the drawings. The drawings are not necessarily at a constant scale, the relative scales of the selected elements are exaggerated for clarity, and elements of similar structure or function are represented by similar reference numbers throughout the drawing. The drawings are intended only to facilitate the description of the examples, and even if they are intended to provide an exhaustive description of the invention, the scope of the invention and its equivalents are defined only in the appended claims. It should be understood that it does not limit the scope of. In addition, the illustrated examples need not have all of the aspects or advantages shown. The embodiments and advantages described in connection with a particular embodiment are not necessarily limited to that embodiment and can be realized in other embodiments without such description.

FIG. 1 shows an embolic device 10 according to an embodiment of the present invention disclosed. The embolic device 10 has an elongated and constrained configuration (FIG. 2A) for placement at a target vascular site 20 (eg, aneurysm sac) through a delivery catheter 80. The embolic device 10 further has a three-dimensional, unconstrained configuration (FIGS. 1 and 2B), where the device 10 is a plurality of continuous loops 12. For example, the device 10 is advanced out of the distal opening 82 of the delivery catheter 80 and / or the delivery catheter 80 is retracted proximally to the embolic device 10 to cause the embolic device 10 (or any number of them). After the catheter has entered the target vessel site 20 (FIG. 2B), the instrument has a three-dimensional, unconstrained configuration. The three-dimensional unconstrained configuration is set by applying a series of steps to manufacture an elongated flat member 100 having continuous loops 12, where the elongated flat member 100 is placed between each of the plurality of loops. Twisted at least partially around the longitudinal axis, the first side surface 14 is outward of each loop 12 towards the inner wall 22 of the aneurysm 20, regardless of the orientation and / or orientation change of the elongated flat member 100. Along with facing, the second side surface 16 faces the inner side 11 of each loop 12 (FIGS. 1 and 2B). As shown in FIGS. 1 and 2B, the plurality of continuous loops 12 define a first loop that defines a first plane and a second loop that defines a second plane that is not coplanar with the first plane. It can include a loop and a third loop that defines a third plane that is not coplanar with either the first and second planes. In some embodiments, as shown in FIG. 2B, the plurality of contiguous loops has at least 5 contiguous loops 12.

A series of manufacturing steps applied to the elongated flat member 100 to set the three-dimensional unconstrained configuration of the embolic device 10 will be described in more detail below.

The elongated flat member 100 forming the embolic device 10 has a proximal portion 140, an intermediate portion 130, and a distal portion 120, as shown in FIG. 3A. The proximal 140 has the proximal end 142 and the distal 120 has the distal end 122. The elongated flat member 100 has a ribbon-like shape with a rectangular cross section, as shown in FIGS. 3A and 3B. Alternatively, the elongated flat member 100 may have other suitable cross sections, eg, oval or oval (FIG. 4A), flat with rounded edges (FIG. 4B), flat. A tubular cross section (FIG. 7B), etc., or a combination thereof. The elongated flat member 100 includes a longitudinal axis 13, a first side portion 4 having a first side surface 14, and a second side portion 6 having a second side surface 16, as shown in FIG. 3A. In addition, the first side portion 4 and the second side portion 6 are opposite to each other so that the first side surface 14 and the second side surface 16 are opposite to each other.

For ease of explanation, the elongated flat member 100 shown in FIGS. 3A-B is composed of a single layer 40 of material having a ribbon-like shape. The single layer 40 of the material may be porous and / or permeable, eg, a layer 40 formed from a plurality of braided wires 50 or a woven filament 50'(FIG. 5A), a mesh 55 (FIG. 5B). ), And / or a single layer 40 of material with perforations 57 (FIG. 5C), or a combination thereof. The wire 50 and / or filament 50'is composed of biocompatible metal and / or polymeric materials, alloys or combinations thereof. For example, one or more wires 50 can have a platinum core, each with an outer layer of nitinol. In some embodiments, the elongated flat member 100 has a single layer flat ribbon braid. When the elongated flat member 100 is woven, woven, or meshed, the proximal end 142 and / or the distal end 122 is fixed by attaching or connecting a plurality of wires 50 to each other, or of FIG. 6A. As shown in the distal end 122, each proximal end 142 and / or the distal end 122 may be secured to another element (eg, cap, non-traumatic tip, etc.), such as with an adhesive or clamping. can. Alternatively, as shown in the distal end 122 of FIG. 6B, the proximal end 142 and / or the distal end 122 of the elongated flat member 100 has a plurality of wires 50 each proximal end 142 and / or distal. It may be freed at the end 122 and not fixed. Further, as shown in the distal end 122 of FIG. 6C, the fixed proximal end 142 and / or the distal end 122 of the elongated flat member 100 may be connected to the coil 123. The coil 123 can be made of a shape memory material, and can have a loop-like shape like the loop 12 of the embolic device 10 when the embolic device 10 has a three-dimensional unconstrained structure. When the coil 123 is placed at the distal end 122 of the elongated flat member 100, the coil 123 can be configured to guide the embolic instrument when placed within the aneurysm 20.

In some embodiments, the elongated flat member 100 comprises a braided body formed of one or more braided members, the one or more braided members being metal filaments or wires.

In a further embodiment, the single layer 40 of the material can be a layer of non-porous or impermeable material (eg, solid), as shown in FIG. 3A. It should be understood that the single layer 40 of the elongated flat member 100 can contain alloys of one or more materials, combinations thereof.

In other embodiments, the elongated flat member 100 can be composed of a plurality of layers 42 (eg, FIG. 7A); the layers are porous / permeable, non-porous / impermeable, and / Or may include one or more materials or combinations thereof as described above. The elongated flat member 100 composed of the plurality of layers 42 may have the shape of the flat ribbon of FIG. 3A. As a non-limiting example, the elongated flat member 100 includes a tubular member 150 as shown in FIG. 7A, where the tubular member 150 is flat as shown in FIG. 3A, such as a flat tubular braid as shown in FIG. 7B. It can include a flattened braid or mesh that forms a ribbon-like shape. The tubular member 150 includes at least two layers 42 as shown in FIG. 7B when flattened into a ribbon-like shape. In another exemplary embodiment, the elongated flat member 100 is composed of a cylindrical member 160 as shown in FIG. 8A and is flattened into the flat ribbon shape of FIG. 3A as shown in FIG. 8B. It is formed like a shape. The cylindrical member 160 can be composed of one or more members or a combination thereof. The cylindrical element 160 of FIGS. 8A-B can further include a core 162 and an outer layer 164. As a non-limiting example, the core 162 may be composed of platinum and the outer layer 164 may be composed of nitinol.

The elongated flat member 100 can be woven from wire, cut from a tube, or cut from a sheet using a variety of techniques, including laser cutting, patterns on tubes or sheets. Etching, or other suitable technique. It should be understood that other suitable configurations of the elongated flat member 100 are also conceivable for the manufacture of the embolic device 10.

Returning to FIG. 3A, the elongated flat member 100 has a length L ₁ in the range of about 2-40 centimeters, and in some embodiments L ₁ is in the range of about 5-25 centimeters. _{The elongated flat member 100 further has a width W 1 in} the range of about 0.5-10 mm, and in some embodiments W ₁ is in the range of about 1-3 mm. Further, the elongated flat member 100 has a thickness T ₁ in the range of about 0.05-0.75 mm, and in some embodiments the T ₁ is about 0.1-0.4 mm. The range. In some embodiments, one or more dimensions (L ₁ , W ₁ or T ₁ ) of the elongated flat member 100 are maintained constant throughout the element 100 and are the same from proximal 140 to distal 120. It is designed to have dimensions. In another embodiment, one or more dimensions of the elongated flat member 100 (L ₁ , W ₁ or T ₁ ) vary and have different dimensions over the length of the elongated flat member 100 (eg, in a tapered configuration). be).

The elongated flat member 100 can be composed of any number of biocompatible, compressible, elastic materials or combinations thereof, as alloys such as polymer materials, metals, and stainless steel, titanium, nitinol. Nickel-titanium alloys such as the known superelastic nickel-titanium alloys can be included. Certain hyperelastic alloys are desirable for shape-recoverable features, allowing large deflections without deformation, even when used on elongated flat members 100 with small dimensions. Further, if the embolic device 10 has an elongated flat member 100 made of a self-expandable material, the unrestrained embolic device 10 is urged to expand into a predetermined deployment configuration, further detailed below. Explained in. Some superelastic alloys are nickel / titanium alloys (48-58 atomic% nickel and moderate amounts of iron selectively contained); copper / zinc alloys (38-42% by weight zinc); 1- Includes 10 wt% copper / zinc alloys including beryllium, silicon, tin, aluminum or gallium; or nickel / aluminum alloys (36-38 atomic% aluminum).

The elongated flat member 100 may have a radiation opaque marker or may be coated with a radiation opaque material layer. Additionally, a bioactive agent or therapeutic agent (eg, a thrombus inducer) can be retained by the elongated flat member 100 and / or coated on the surface of the elongated flat member 100.

Further suitable metals and alloys for the elongated flat member 100 include platinum group metals such as platinum, rhodium, palladium, renium, and alloys of these metals such as tungsten, gold, silver, tantalum, and platinum / tungsten alloys. And so on, these combinations are included. These metals have significant radiodensity and their alloys can be adjusted to achieve the proper combination of flexibility and rigidity.

FIG. 9 illustrates the embolic device 10 of FIG. 1 having an elongated flat member 100, which is manufactured using the mandrel 200 according to the disclosed embodiment of the present invention. An elongated flat member 100 is placed on top of the mandrel 200. The mandrel 200 comprises a handle post 210 extending from the proximal 240 to the distal 220. The distal portion 220 of the mandrel 200 comprises a plurality of elongated posts 230, 232, 233, 234, 236 and 238. The handle post 210 and the laterally elongated posts 230, 232, 233, 234, 236 and 238 have a cylindrical or tubular shape with a round cross section. Alternatively, the handle post 210 and the laterally elongated posts 230, 232, 233, 234, 236 and 238 can also have other suitable shapes, such as those having an elliptical cross section. The stretched posts 230, 232, 233, 234, 236 and 238 extend from the distal portion 220 of the handle post 210 and are located around the distal portion 220 of the handle post 210. Each stretch post 230, 232, 233, 234, 236 and 238 has a center point (eg, 238'), respectively, and as shown in FIG. 9, each stretch post is relative to the center point of an adjacent post. Are arranged at an appropriate angle (eg, about 65-95 degrees). In an alternative embodiment, the mandrel 200 comprises four extension posts and is located at about 90 degrees to the center point of adjacent posts (not shown). The mandrel 200 may have any number of stretch posts and any angle between the stretch posts (eg, the posts can be arranged symmetrically or asymmetrically with each other), or the mandrel of FIG. It should be understood that other suitable configurations for manufacturing the embolic device 10 can be made, as in the example of 200'. The mandrel 200'of FIG. 10 has a flat base 240 and a plurality of stretching posts 250, 251, 252, 255, 254, 255 and 256 extending outward from the base 240.

The elongated flat member 100 is disposed on the mandrel 200 by disposing the elongated flat member 100 specifically with respect to either the first side surface 14 or the second side surface 16 with respect to the mandrel 200. For example, if the first side surface 14 of the elongated flat member 100 is installed, placed, or in contact with the mandrel 200, although not shown, the second side surface 16 manufactures the embolic device 10. It is exposed and visible to the technician (ie, not in contact with the Mandrel 200). Conversely, if a second side surface 16 of the elongated flat member 100 is installed, placed, or in contact with the mandrel 200, then the first side surface 14 of the elongated flat member 100 is FIGS. 9 and 10. As shown in, it is exposed and visible to the technician manufacturing the embolic device 10 (ie, not in contact with the mandrel 200).

In a three-dimensional, unconstrained configuration of the embolic device 10, the elongated flat member 100 becomes a plurality of continuous loops 12, and the elongated flat member 100 is at least a portion around the longitudinal axis between each of the plurality of loops. The first side surface 14 faces the outside of each loop 12 and the second side surface 16 faces each loop regardless of the direction and / or orientation change of the elongated flat member 100. It faces the inside of the twelve. By arranging and winding the elongated flat member 100 on the mandrel (eg, FIGS. 9 and 10) to form a plurality of continuous loops 12, a three-dimensional unconstrained configuration of the embolic device 10 is set. The elongated flat member 100 is twisted at least partially around the longitudinal axis between each post of the mandrel to form a plurality of loops, respectively, as shown in FIGS. 9 and 10. Regardless of the direction and / or orientation change of 100, the first side surface 14 faces the outside of each post and / or loop, and the second side surface 16 faces the inside of each loop, at least partially, respectively. It comes in contact with the post.

In the disclosed embodiments of the invention, at least a partial twist of the elongated flat member 100 around the longitudinal axis between each loop and / or between each post is depicted in FIG. The partial twist around the longitudinal axis of the elongated flat member 100 is approximately 120 degrees and is elongated flat when the embolic device 10 is in a three-dimensional unconstrained configuration as in FIGS. 1 and 2B. Regardless of the orientation and / or change in orientation of the member 100, the first side surface 14 of the elongated flat member 100 faces the outside of each loop 12, and the second side surface 16 of the elongated flat member 100 faces each loop. It is designed to face the inside of. In a three-dimensional, unconstrained configuration of the embolic device 10, one side surface (eg, first side surface 14) of the elongated flat member 100 is each, regardless of changes in direction and / or orientation of the elongated flat member 100. Partial twisting is an elongated flat member as long as it faces the outside of the loop 12 and the opposite side of the elongated flat member 100 (eg, the second side 16) faces the inside 11 of each loop 12. It should be understood that other suitable angles around the 100 longitudinal axis may be included.

Further, the angle between the continuous loops 12 can be expressed as a pitch having the amount of twist angle per unit length. The twist pitch is preferably about 1-2 times the pitch of 360 ° / πD in relation to the diameter of the adjacent loop 12, where D is the average curve diameter of the adjacent loop 12. The twist pitch may vary by about 0.25 to about 4 times (360 ° / πD), and in some embodiments the twist pitch may vary from about 0.75 to about 0.75 to about (360 ° / πD). It may be varied by 2.5 times. In one embodiment, the twist of the elongated flat member 100 forming the three-dimensional unconstrained configuration of the embolic device 10 generally occurs to have a constant cross section of the elongated flat member 100 throughout the twist. Alternatively, the twist may occur so that the cross section of the elongated flat member 100 changes throughout the twist.

For illustration, FIG. 12 shows an undesired partial twist (eg 60 °) of an elongated flat member 100 around a longitudinal axis between each loop and / or between each post. Due to this twist, the first side surface 14 of the elongated flat member 100 faces outward and inward in the alternating loops, and the second side surface 16 of the elongated flat member 100 faces outward and inward in the alternating loops. It is not desirable because it is.

The steps of placing an elongated flat member 100 on top of a mandrel 200, stacking, winding and / or twisting are described in more detail below, according to the disclosed invention. After the elongated flat member 100 is placed on the mandrel 200 to form a three-dimensional structure of the embolic device 10, the embolic device 10 is heat-treated to extend the elongated flat member 100 outward from the mandrel. A plurality of continuous loops 12 are formed by wrapping around the post in alternating directions. By heat-treating the elongated flat member 100 as described above, the embolic device 10 is urged to have a three-dimensional unconstrained shape as shown in FIGS. 1 and 2B. Is given a three-dimensional unconstrained shape. The mandrel 200 is made of a material having sufficient heat resistance that enables heat treatment of the embolic device 10. Mandrel 200 typically comprises a refractory material such as alumina or zirconia, or other suitable heat resistant material.

FIG. 13 shows a method 300 for manufacturing an embolic device 10 using the above-mentioned elongated flat member 100 and a mandrel 200 according to the disclosed embodiment of the present invention.

In step 302, either the proximal end 142 or the distal end 122 of the elongated flat member 100 is first placed on the mandrel 200 and either the first side surface 14 or the second side surface 16 is the mandrel. Come into contact with 200. As a non-limiting example, the proximal end 142 of the elongated flat member 100 is placed on the handle posts 210 located proximal to the extension posts 230, 232, 233, 234, 236 and 238, as shown in FIG. As described above, a part of the second side surface 16 comes into contact with the mandrel 200.

In step 304, an elongated flat member 100 is partially twisted around its longitudinal axis and further placed around a first extension post to form a loop, with the first side surface outward (eg, eg). The second side should face inward (eg, the side facing the post or the side partially in contact with the post) facing away from the post. For example, the elongated flat member 100 is partially twisted and wound clockwise around the first stretch post 230, as shown in FIG. 9, with a portion of the second side surface 16 being the stretch post 230. It is extended so as to come into contact with.

In step 306, an elongated flat member 100 is partially twisted around its longitudinal axis and further placed around a second extension post to form a loop, with the first side surface outward (eg, eg). The second side should face inward (eg, the side facing the post or the side partially in contact with the post) facing away from the post. As shown in FIG. 9, the elongated flat member 100 is partially twisted and wound counterclockwise around the second extension post 232, with a portion of the second side surface 16 being the extension post 232. It extends to touch.

In step 308, an elongated flat member 100 is partially twisted around its longitudinal axis and further placed around a third extension post to form a loop, with the first side surface outward (eg, eg). , The side away from the post) so that the second side faces inward (eg, the side facing the post or the side partially in contact with the post). As shown in FIG. 9, the elongated flat member 100 is partially twisted and wound clockwise around the third extension post 233, with a portion of the second side surface 16 being the third extension post. It extends so as to come into contact with 233.

In step 310, an elongated flat member 100 is partially twisted around its longitudinal axis and further placed around a fourth extension post to form a loop, with the first side surface outward (eg, eg). The second side should face inward (eg, the side facing the post or the side partially in contact with the post) facing away from the post. As shown in FIG. 9, the elongated flat member 100 is partially twisted and wound counterclockwise around the fourth extension post 234, with a portion of the second side surface 16 being the extension post 234. It extends to touch.

In step 312, an elongated flat member 100 is partially twisted around its longitudinal axis and further placed around a fifth extension post to form a loop, with the first side surface outward (eg, eg). The second side should face inward (eg, the side facing the post or the side partially in contact with the post) facing away from the post. For example, the elongated flat member 100 is partially twisted and wound clockwise around the fifth stretching post 236, as shown in FIG. 9, with a portion of the second side surface 16 being stretched post 236. It is extended so as to come into contact with.

In step 314, an elongated flat member 100 is partially twisted around its longitudinal axis and further placed around a sixth extension post to form a loop, with the first side surface outward (eg, eg). The second side should face inward (eg, the side facing the post or the side partially in contact with the post) facing away from the post. As shown in FIG. 9, the elongated flat member 100 is partially twisted and wound counterclockwise around the sixth extension post 238, with a portion of the second side surface 16 being the extension post 238. It extends to touch.

In step 316, the elongated flat member 100 is heat treated to provide a three-dimensional, unconstrained shape of the embolic device 10 as shown in FIGS. 1 and 2B.

In any step 318 prior to step 316, the elongated flat member 100 is further partially twisted and alternately arranged clockwise and counterclockwise around the handle post and / or extension post to elongated flat. The surface of the member 100 is at least partially in contact with the stretch post and the handle post.

In steps 302 to 316, the transition of the elongated flat member 100 from one post to the other post of the mandrel 200 is wavy and separated, with at least one (eg 16) sides of the elongated flat member 100 being at least a portion. Allows the opposite side (eg, 14) to be free, visible, or exposed (ie, not in contact with the mandrel 200) at the same time as it is in contact with the mandrel 200. Should be understood.

The embolic device 10 obtained from the manufacturing process described above comprises a three-dimensional unconstrained configuration with a plurality of continuous loops, and an elongated flat member 100 is provided around a longitudinal axis between each of the plurality of loops. At least partially twisted, with the first side 14 facing the outside of each loop, regardless of changes in orientation and / or orientation of the elongated flat member, as shown in FIGS. 1 and 2B. , The second side surface 16 faces the inside of each loop. The side surface (eg, surface 16) of the elongated flat member 100 placed on the mandrel 200 during the manufacturing process faces the inside 11 (eg, concave portion) of each loop 12, while the manufacturing process. The side surface (eg, surface 14) of the elongated flat member 100 that is not in contact with the mandrel 200 between the two is each of the embolic devices 10 in a three-dimensional unconstrained configuration, as shown in FIGS. 1 and 2B. It faces the outer 12 of the loop (eg, a convex portion).

A feature of the three-dimensional unrestrained configuration of the embolic device 10 provides several important advantages, which are to be used as an embolic device for use in small diameter sites such as neurovascular aneurysms. First, the embolic device 10 has separate transition regions (eg, loops, partial twists) that allow it to be highly compressed or contracted with relatively little bending or stress. This is in contrast to embolic instruments with sharp twists, bends, or turns, such embolic instruments are inefficiently packed and cannot be compressed tightly due to the relatively coarse transition area. .. Similarly, the pressure of an embolic device with sharp twists, bends, turns, and overlaps will result in more contacts and friction for the embolic device with a delivery system, especially while traveling through a winding vascular path. , (For example, delayed placement of the embolic device, metal fatigue of the embolic device, etc.) have undesired effects.

Further, when the embolic device 10 is placed in the aneurysm 20 through the delivery catheter 80, exits the delivery catheter 80 and is placed in the aneurysm, and then has a three-dimensional unrestrained configuration (FIG. 2A). In −B), the elongated flat member 100 becomes a plurality of continuous loops 12 that are at least partially twisted around the longitudinal axis between each of the plurality of loops 12 to form an elongated flat member 100. Regardless of the orientation and / or orientation change, the first side surface 14 faces the outside of each loop 12 towards the inner wall 22 of the aneurysm 20, and the second side surface 16 is the inside 11 of each loop. The first side surface 14 of the device 10 has an aneurysm without swelling or sharp turns or angles that can damage or rupture the inner wall 22 of the aneurysm. It is engaged and in contact with the inner wall 22 of 20.

It should be understood that the disclosed embolic device 10 constructed according to the present invention can be delivered to the target site by a known method.

Although certain embodiments have been shown and described herein, one of ordinary skill in the art understands that they are not intended to limit the invention and are solely subject to the following claims and their equivalents. It will be apparent to those skilled in the art that various modifications, substitutions and improvements (eg, various component dimensions, component combinations, etc.) can be made without departing from the defined and disclosed claims. Therefore, the specification and drawings should be regarded as exemplary rather than limiting. The various examples presented and described herein also cover the disclosed alternatives, improvements, and equivalents of the invention that may be included within the appended claims.

Claims (20)

In embolic equipment
An elongated flat member having a longitudinal axis, a first side portion including a first side surface, and a second side portion including a second side surface, wherein the first side surface and the second side surface are provided. The first side portion and the second side portion are provided with an elongated flat member whose front and back sides are opposite to each other so that the side surfaces of the first side portion and the second side portion are opposite to each other.
The elongated flat member has an elongated constrained configuration for placement at a target vessel site through a delivery catheter and a three-dimensional unconstrained configuration.
In the three-dimensional unconstrained configuration, the elongated flat member becomes a plurality of continuous loops, and the elongated flat member is twisted at least partially around a longitudinal axis between each of the plurality of loops. , The first side surface faces the outside of each loop and the second side surface faces the inside of each loop, regardless of changes in the orientation and / or orientation of the elongated flat member. Embolic device to do. The embolic device according to claim 1, wherein the elongated flat member includes a braided body formed of one or more braided members. The embolic device according to claim 2, wherein one or more of the braided members are metal filaments or wires. The embolic device according to claim 2 or 3, wherein the elongated flat member comprises a flat tubular braid. The embolic device according to claim 2 or 3, wherein the elongated flat member comprises a single-layer flat ribbon braid. In the embolic device according to any one of claims 1 to 5, the elongated flat member is heat-treated to impart the three-dimensional unconstrained configuration to the elongated flat member. An embolic device characterized in that a plurality of continuous loops are formed by winding an elongated flat member in alternating directions around each post extending outward from the mandrel. In the embolic device according to any one of claims 1 to 6, the plurality of continuous loops are not coplanar with the first loop defining the first plane. An embolic device comprising a second loop defining two planes and a third loop defining a third plane that is not coplanar with either the first or second plane. The embolic device according to any one of claims 1 to 7, wherein the plurality of continuous loops include at least five continuous loops. The embolic device according to any one of claims 1 to 8, wherein the elongated flat member has a twisting pitch. The embolic device according to claim 9, wherein the twist pitch is about 1.5 times 360 ° / πD, where D is the average curve diameter of adjacent loops. The embolic device according to claim 10, wherein the twist pitch fluctuates by about 0.25 to about 4 times (of 360 ° / πD). The embolic device according to claim 10, wherein the twist pitch fluctuates by about 0.75 to 2.5 times (of 360 ° / πD). In the embolic device according to any one of claims 1 to 12, the elongated flat member twisted at least partially around a longitudinal axis between the plurality of loops has a constant cross section through the twist. An embolic device characterized by having. In the embolic device according to any one of claims 1 to 12, the elongated flat member twisted at least partially around a longitudinal axis between each of the plurality of loops has a cross section that changes through twisting. An embolic device characterized by having. In an embolic device that occludes an aneurysm, the embolic device
With an elongated flat braid formed from one or more metal braided filaments or wires,
The elongated flat braid has a longitudinal axis, a first side portion with a first side surface, and a second side portion with a second side surface, the first side portion. The first side portion and the second side portion are opposite to each other so that the side surface and the second side surface are opposite to each other.
An elongated restrained configuration for the elongated flat braid to be placed in the aneurysm through the delivery catheter and a three-dimensional unconstrained structure after exiting the delivery catheter and being placed in the aneurysm. Has a configuration and
In the three-dimensional unconstrained configuration, the elongated flat braid becomes a plurality of continuous loops, and the elongated flat braid is screwed at least partially around the longitudinal axis between the plurality of loops. The first side surface faces the outer wall of each loop and faces the inner wall of the aneurysm, regardless of changes in the orientation and / or orientation of the elongated flat braid. An embolic device characterized in that the sides face the inside of each loop. The embolic device according to claim 15, wherein the elongated flat braid comprises a flat tubular braid. The embolic device according to claim 15, wherein the elongated flat braid comprises a single-layer flat ribbon braid. In the embolic device according to any one of claims 15 to 17, the elongated flat braid is heat-treated to impart the three-dimensional unconstrained configuration to the elongated flat braid. , An embolic device characterized in that a plurality of continuous loops are formed by winding the elongated flat braid in alternating directions around each post extending outward from the mandrel. The embolic device according to any one of claims 15 to 17, wherein the plurality of continuous loops are not coplanar with the first loop defining the first plane. An embolic device characterized by having a second loop defining two planes and a third loop defining a third plane that neither of the first and second planes is coplanar with. .. The embolic device according to any one of claims 15 to 19, wherein the plurality of continuous loops include at least five continuous loops.

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